NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S034 · decided 1996-09-09
Approval details
- PMA number
- P890027
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1996-06-06
- Decision date
- 1996-09-09
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APRPOVAL FOR IMPLEMENTING A TEST SYSTEM TO CONFIRM OR RULE OUT POTENTIAL IMPLANT MALFUNCTION AND FOR MARKETING OF ONE OF THE COMPONENTS OF THIS TEST SYTEM AS A SEPARATE DEVICE
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